APPLICATION
ANDA065093
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-21
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 875MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 33 · standardAP
2023-02-23Labeling · Supplement 32 · standardAP
2014-09-25Labeling · Supplement 17 · standardAP
2010-05-20Labeling · Supplement 12AP
2009-09-29Labeling · Supplement 10AP
2006-07-31Labeling · Supplement 6AP
2005-09-01Labeling · Supplement 5AP
2004-03-26Labeling · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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